Von Birgelen_DUTCH PEERS II

Report
TCT 2013: Late Breaking Clinical Trials III – Thursday, October 31, 2013. 10:20–10:32 P.M. – Main Arena.
DUTCH PEERS (TWENTE II):
A Prospective, Randomized, "All-Comers" Trial of
Third-Generation Zotarolimus-Eluting vs.
Everolimus-Eluting Coronary Stents
Clemens von Birgelen1,2, Hanim Sen1, Ming Kai Lam1, Peter W. Danse3, Gillian A.J. Jessurun4,
Raymond W.M. Hautvast5, K. Gert van Houwelingen1, Alexander R. Schramm4, R. Melvyn Tjon
Joe Gin3, J.(Hans) W. Louwerenburg1, Frits H.A.F. de Man1, Martin G. Stoel1, Marije M. Löwik1,
Gerard C.M. Linssen6, Salah A.M. Saïd6, Mark B. Nienhuis7, Patrick M.J. Verhorst1,
Mounir W.Z. Basalus1, Carine J.M. Doggen2, Kenneth Tandjung1
1Thoraxcentrum
Twente, Medisch Spectrum Twente, Dpt. of Cardiology, Enschede, 2Dpt. of Health Technology and Services Research, University of Twente, Enschede,
Hospital, Dpt. of Cardiology, Arnhem, 4Scheper Hospital, Dpt. of Cardiology, Emmen, 5Medical Center Alkmaar, Dpt. of Cardiology, Alkmaar,
6Hospital Group Twente, Dpt. of Cardiology, Almelo and Hengelo, 7Queen Beatrix Hospital, Dpt. of Cardiology, Winterswijk, the Netherlands
3Rijnstate
Disclosure Statement
C. von Birgelen, MD PhD
 Institutional Research Grant: Abbott Vascular, Biotronik, Boston
Scientific, Medtronic
 Consultancy: Abbott Vascular, Boston Scientific, Medtronic
 Travelling Expenses: Biotronik
 Speakers Honorarium: Biotronik and MSD
 Major Stock Shareholder / Equity
 Royalty Income
 Ownership / Founder
 Intellectual Property Rights
 Other Financial Benefit
Background
• Second-generation drug-eluting stents (DES) with
biocompatible durable coatings are efficacious and safe.
• Third-generation durable coating DES use the same
coatings but have novel stent platforms with more
flexible designs. They may be delivered more easily in
complex lesions but might be longitudinally less stable.
• Outcome data for Promus Element were published, but
no such data were available for Resolute Integrity.
• We investigated in all-comers whether clinical outcome
is similar following randomized use of both DES.
Study Devices
RESOLUTE
INTEGRITY
PROMUS
ELEMENT
Polymer component
BioLinx®, a blend of
hydrophobic C10 polymer,
hydrophilic C19 polymer &
poly-vinyl pyrrolidone
Fluoropolymer
coating
Thickness of coating layer
5.6 µm
7 µm
Antiproliferative drug
Zotarolimus
Everolimus
Drug release period
180 days
120 days
Material of metal
stent platform
Cobalt-chromium
Platinum-chromium
Strut thickness of metal
stent platform
91 μm
81 μm
Stent manufacturer
Medtronic
Boston Scientific
Tandjung et al. DUTCH PEERS: Study design and rationale. Am Heart J 2012; 163: 557-62
DUTCH PEERS
(TWENTE II)
 Any patient requiring DES (stable angina, any ACS, including STEMI)
 No limit of number of lesions or vessels treated, lesion length, vessel size, or
lesion type (de novo lesion, restenosis, CTO, graft lesion)
 Inclusion criteria: Age ≥ 18 yrs; patient requires PCI with DES implantation and is able
and willing to comply with study procedures and follow-up procedures; signed
informed consent
 Exclusion criteria: Participation in another randomized drug or device trial before
reaching its primary endpoint; life expectancy < 1yr; planned surgery < 6 mo’s of PCI
unless DAPT is maintained; known pregnancy; intolerance to heparin, ASA,
clopidogrel, or DES components
Zotarolimus-eluting
RESOLUTE INTEGRITY
1811 All-comer patients were enrolled in this singleblinded, investigator-initiated, randomized (1:1)
trial in Arnhem, Emmen, Alkmaar & Enschede
(n=906)
Everolimus-eluting
PROMUS ELEMENT
(n=905)
30 days
1 year
2 years
Primary endpoint
Target vessel failure at one year (composite of cardiac death, target vessel-related MI,
and clinically driven target vessel revascularization; non-inferiority hypothesis)
Secondary endpoints Components of primary endpoint; stent thrombosis; patient oriented composite endpoint
Enrollment: November 25, 2010 to May 24, 2012. Systematic (serial) assessment of cardiac markers and ECG. Monitoring of informed consent and key demographic data in all patients;
monitoring of data on potential clinical events in patients with event triggers; in-depth monitoring of all data in 10% of randomly chosen patients. Monitoring performed by CRO Diagram,
Zwolle, NL. Processing of clinical outcome data and independent external adjudication of clinical events (CEC) by CRO Cardialysis, Rotterdam, NL.
Control angiography only if clinically indicated. Analyses based on intention-to-treat.
Tandjung et al. DUTCH PEERS: Study design and rationale. Am Heart J 2012;163:557-62.
von Birgelen et al. DUTCH PEERS. Lancet – in press.
Investigator-initiated study, equally funded by Boston Scientific and Medtronic
Eligibility of Patients
Inclusion Criteria
Exclusion Criteria
• Indication for DES use
• Participation in drug or device RCT
• Age ≥ 18 years
• Life expectancy < 1 year
• Signed informed consent
• Planned surgery < 6 months of PCI
• Willing to comply with study and
follow-up procedures
unless DAPT was maintained
• Known pregnancy
• Intolerance to heparin, ASA,
clopidogrel, or DES components
Power Calculation of Primary
Clinical Endpoint
Target Vessel Failure at 12 Months
A composite of cardiac death, target vessel-related MI,
and clinically driven target vessel revascularization
• Event rates at 12 months would be equal in both groups
• Non-inferiority margin of 3.6%, expecting 10% events based on
data of Resolute All-Comers, at a one-sided type-I error of 0.05
1788 patients would yield 80% power
to detect non-inferiority
Study Flow Diagram
3954 patients: treated by PCI with DES*
3224 patients: eligible for enrollment
1811 patients: enrolled and randomized
Randomization (1:1)
906 patients: Resolute Integrity
905 patients: Promus Element
905 patients: 1-year follow-up**
905 patients: 1-year follow-up
• 56% of eligible patients enrolled
• Follow-up data obtained in 99.9% of patients
* Patients treated during study enrollment; ** One patient withdrew consent. Monitoring was performed by CRO
Diagram, Zwolle, NL. Data entry by CRO CardioResearch Enschede, Enschede, NL. Independent clinical event
adjudication (CEC) was performed by CRO Cardialysis, Rotterdam, NL. Analyses were based on intention-to-treat.
Patient Characteristics
Age (yrs)
Men
BMI (kg/m²)
Diabetes mellitus
Chronic renal failure*
Arterial hypertension
Hypercholesterolemia
Current smoker
Family history of CAD
Previous MI
Previous PCI
Previous CABG
Clinical indication
Stable angina
Unstable angina
Non-ST-elevation MI (NSTEMI)
ST-elevation MI (STEMI)
Left ventricular ejection fraction < 30%
Resolute Integrity
n = 906 pts.
Promus Element
n = 905 pts.
64 (56-72)
665 (73.4)
27.1 (25.0-30.0)
167 (18.4)
35 (3.9)
500 (55.2)
418 (46.1)
213 (23.6)
452 (50.1)
207 (22.8)
182 (20.1)
84 (9.3)
65 (57-72)
657 (72.6)
27.2 (24.9-30.5)
157 (17.3)
28 (3.1)
484 (53.5)
430 (47.5)
231 (25.5)
451 (49.9)
190 (21.0)
167 (18.5)
89 (9.8)
372 (41.1)
113 (12.5)
246 (27.2)
175 (19.3)
377 (41.7)
132 (14.6)
201 (22.2)
195 (21.5)
15 (1.7)
13 (1.4)
Data are frequencies (%) or mean (SD). No significant difference between study groups.
* Serum creatinine level ≥ 130 μmol/L.
P
0.86
0.70
0.48
0.55
0.37
0.47
0.56
0.61
0.98
0.34
0.38
0.68
0.07
0.70
Lesion Characteristics
Target lesion coronary artery
Left main
Left anterior descending
Left circumflex
Right coronary artery
Bypass graft
ACC-AHA lesion class
A/B1
B2/C
De novo lesion
Chronic total occlusion
In stent restenosis
Aorta ostial lesion
Severe calcification
Bifurcated lesion
Thrombus present
Total occlusion
Pre-procedural TIMI flow grade
0
1
2
3
Resolute Integrity
n = 1205 lesions
Promus Element
n = 1166 lesions
19 (1.6)
493 (40.9)
304 (25.2)
378 (31.4)
30 (2.5)
21 (1.8)
469 (40.2)
280 (24.0)
379 (32.5)
35 (3.0)
412 (34.2)
793 (65.8)
1147 (95.2)
38 (3.2)
28 (2.3)
59 (4.9)
221 (18.3)
282 (23.4)
165 (13.7)
167 (13.9)
401 (34.4)
765 (65.6)
1103 (94.6)
39 (3.3)
28 (2.4)
65 (5.6)
251 (21.5)
249 (21.4)
174 (14.9)
153 (13.1)
175 (14.5)
40 (3.3)
128 (10.6)
862 (71.5)
155 (13.3)
39 (3.3)
125 (10.7)
847 (72.6)
Data are frequencies (%) or mean (SD). No significant difference between study groups.
* Thrombus triggering use of thrombus aspiration catheter.
P
0.67
0.73
0.49
0.55
0.45
0.99
0.51
0.79
0.90
0.46
0.052
0.23
0.40
0.60
0.86
Procedural Data (Patient-based)
Resolute Integrity
n = 906 pts.
Promus Element
n = 905 pts.
Total number of lesions treated per patient
P
0.32
1 lesion treated
668 (73.7)
688 (76.0)
2 lesions treated
191 (21.1)
182 (20.1)
47 (5.2)
35 (3.9)
817 (90.2)
810 (89.5)
0.64
38 (4.2)
38 (4.2)
1.00
At least one bifurcation lesion treated
244 (26.9)
221 (24.4)
0.22
At least one in-stent restenosis treated
27 (3.0)
28 (3.1)
0.89
At least one small-vessel (RVD < 2.75 mm) tr.
551 (60.8)
517 (57.1)
0.11
At least one long lesion (> 27 mm) treated
161 (17.8)
157 (17.3)
0.81
Glycoprotein IIb/IIIa antagonist administered
262 (28.9)
259 (28.6)
0.89
3 or more lesions treated
Only de novo coronary lesions treated*
At least one chronic total occlusion treated
Data are frequencies (%). No significant difference between study groups.
* Including chronic total occlusion, but not grafts or in-stent restenosis.
Procedural Data (Lesion-based)
Resolute Integrity
n = 1205 lesions
Promus Element
n = 1166 lesions
P
13.63 (9.58-20.41)
13.46 (9.56-20.68)
0.74
Diameter of reference vessel (mm)
2.64 (2.25-3.06)
2.66 (2.27-3.07)
0.28
Minimum lumen diameter (mm)
0.88 (0.63-1.18)
0.88 (0.61-1.23)
0.77
65.25 (53.83-75.84)
64.48 (53.92-76.17)
0.91
2.22 (1.80-2.64)
2.15(1.78-2.58)
0.06
15.07 (10.58-21.17)
15.73 (10.86-21.63)
0.24
1.27 (0.85-1.78)
1.24(0.79-1.77)
0.38
Number of stents implanted per patient
1.80 (1.08)
1.76 (1.10)
0.41
Number of stents implanted per lesion
1.35 (0.68)
1.36 (0.70)
0.70
Total stent length (mm) per patient
30 (18-50)
28 (20-48)
0.64
Total stent length (mm) per lesion
22 (18-36)
24 (16-38)
0.10
Direct stenting
352 (29.2)
326 (28.0)
0.50
Postdilatation
887 (73.6)
920 (78.9)
0.002
3.00 (2.50-3.50)
3.00 (2.50-3.50)
0.09
Implantation of study stents only
1195 (99.2)
1161 (99.6)
0.22
Device success
1194 (99.1)
1158 (99.3)
0.54
Lesion success
1203 (99.8)
1162 (99.7)
0.39
Procedure success
884 (97.6)
890 (98.3)
0.25
Lesion length (mm)
Stenosis (lumen diameter, %)
Postprocedure minimum lumen diameter (mm)
Postprocedure stenosis (lumen diameter, %)
Acute gain in segment (mm)
Maximum stent diameter per lesion (mm)
Data are frequencies (%) or median (IQR).
Primary Endpoint
Target Vessel Failure at 1-Year Follow-up
-0.5
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
4.0
4.5
Non-inferiority margin = 3.6 %
Resolute Integrity
6.1 %
Promus Element
5.2 %
Absolute difference = 0.88 %
Upper 1-sided 95% CI = 2.69 %
Pnon-inferiority = 0.006
5.0 %
Primary Endpoint
Target Vessel Failure at 1-Year Follow-up
Cumulative incidence of events [%]
Cumulative incidence of TVF events (%)
10
Resolute Integrity
Resolute
Integrity
Promus
Element
55/905 (6.1 %) vs.
Promus Element 47/905 (5.2 %)
Pnon-inferiority = 0.006
9
8
7
6
5
4
3
P Log-Rank = 0.40
2
Resolute Integrity 6.1 %
Promus Element 5.2 %
1
0
0
30
60
90
120
150
180
210
240
Time Follow-up
after initial procedure
(days) [days]
Events displayed in the graph (right lower corner) were calculated by Kaplan-Meier methods and compared
with the log-rank test. Non-inferiority testing was based on chi-squared analysis (blue panel).
270
300
330
360
0
60
120
180
240
Components of TVF at 1-Year Follow-up
0
Cardiac Death
Resolute Integrity 1.7 %
Promus Element 1.1 %
15
Xience V
Endeavor R
7
66
At 1-year follow-up, there was
P Log-Rank = 0.311
20
5
44
25
3
30
Time af ter initial procedure [day s]
180
240
300
360
420
480
540
600
660
720
0
0
60
120
0
1
120
22
no statistically significant
difference between Resolute
Integrity and Promus Element
stent groups in the components
of Target Vessel Failure (TVF).
60
88
0
Promus Element
10
(%)
death(%)
cardiac
ofevents
incidence
Cumulative
Cumulative
incidence
[%]
death
Cardiac
of of
incidence
Cumulative
5
Resolute Integrity
9
Cumulative incidence of events [%]
10
10
180
240
00
90
90
180
180
210
210
300
300
330
330
360
360
P Log-Rank = 0.154
15
Xience V
Endeavor R
20
5
44
25
3
22
30
1
00
00
30
30
60
60
90
90
120
120
150
150
180
180
210
210
240
240
Follow-up
(days)[days]
Time after
initial procedure
270
270
300
300
330
330
Resolute Integrity
Clinically indicated TVR
Promus Element
9
88
Resolute Integrity 2.7 %
Promus Element 2.9 %
360
360
7
66
P Log-Rank = 0.787
5
44
3
22
30
10
Resolute Integrity 2.2 %
Promus Element 1.3 %
TVR (%)
indicated
of clinically
Cumulative incidence
Cumulative incidence
of events
[%]
TV-related MI
25
Promus Element
10
10
20
9
66
270
270
Xience V
Endeavor R
5
Resolute Integrity
7
240
240
Cumulative incidence of events [%]
10
10
88
150
150
Follow-up
(days)[days]
Time after
initial procedure
Cumulative incidence of events [%]
Cumulative
incidence
of events
[%] MI (%)
of target
incidence
Cumulative
vessel
120
120
15
60
60
10
30
30
5
00
1
00
00
30
30
60
60
90
90
120
120
150
150
180
180
210
210
240
240
Follow-up
(days)[days]
Time after
initial procedure
TV-related MI: In each study group (Resolute Integrity and Promus Element), 3 patients (0.3%) developed a
periprocedural MI (PMI) with max. CK levels ≥ 5x the ULN; all other PMI had max. CK levels < 5x the ULN.
Events displayed in the graph were calculated by Kaplan-Meier methods and compared with the log-rank test.
TV-related MI was defined by the extended historical definition (Vranckx et al. (ARC), EuroIntervention 2010;5:871-4).
270
270
300
300
330
330
360
360
Cumulative incidence of events [%]
Composite Clinical Endpoints at 1-Year
10
15
Xience V
Endeavor R
Resolute Integrity
Promus Element
20
25
5.6 %
9.3 %
8.0 %
6.4 %
6.1 %
5.2 %
4.5 %
4.9 %
30
P = 0.29
P = 0.42
P = 0.15
P = 0.32
TLF
TVF
MACE
POCE
Target Lesion Failure (TLF): cardiac death, target lesion-related MI & clinically indicated target lesion revascularization.
Target Vessel Failure (TVF, the primary endpoint of the trial): cardiac death , target vessel related MI & clinically
indicated target vessel revascularization. Major Adverse Cardiac Events (MACE): any death, any MI, clinically indiicated TLR & emergent CABG. Patient-Oriented Composite Endpoint (POCE): any death, any MI, any PCI & any CABG.
Medication at 1-Year
84.9 %
95.8 %
84.9 %
11.2 %
ASA
P2Y12 RI
VKA
10.6 %
DAPT
P2Y12 RI
+ VKA
Between stent arms, there was no significant difference in medication. Data on the use of antiplatelet drugs and/or
oral anticoagulation were available in 1810 patients. ASA=acetylsalicylic acid; P2Y12 RI=P2Y12 receptor inhibitor;
VKA=vitamin K antagonist; DAPT=dual antiplatelet therapy.
25
C umulativ e incidence of events [%]
Cumulative incidence of stent thrombosis (%)
Stent Thrombosis at 1-Year
20
Promus
Xience V Element
Resolute
Endeavor R Integrity
15
* Off-DAPT
Probable stent thrombosis
Definite stent thrombosis
Cardiac Death
Myocardial Infarction
Target-Vessel Revascularization
10
Cardiac Death
Myocardial Infarction
Minor Myocardial Infarction
5
0.88 %
0
0
60
120
180
240
300
360
420
480
540
600
660
720
Time after initial procedure [days]
0.55 %
Resolute Integrity 5/906 vs. Promus Element 8/905
P Log-Rank = 0.40
Follow-up (days)
Definite stent thrombosis occurred in 3 patients (0.33 %) of the Resolute Integrity stent group and in 6 patients
(0.66 %) of the Promus Element stent group (P = 0.51). There was no definitive stent thrombosis beyond 3 months.
Events displayed in the graph were calculated by Kaplan-Meier methods and compared with the log-rank
test. Stent thrombosis was defined according to the Academic Research Consortium (ARC).
TVF Subgroup Analysis at 1-Year
Resolute Integrity Promus Element
n = 906
n = 905
Relative Risk
(95% CI)
P
Off-label indication
42/648 (6.5)
32/617 (5.2)
1.25 (0.80-1.95)
0.33
RVD < 2.75mm
41/550 (7.5)
31/517 (6.0)
1.24 (0.79-1.95)
0.34
Acute MI < 72 hr
11/285 (3.9)
6/258 (2.3)
1.66 (0.62-4.42)
0.31
Multivessel PCI
11/163 (6.7)
13/133 (9.8)
0.69 (0.32-1.49)
0.34
Diabetes
10/167 (6.0)
12/157 (7.6)
0.78 (0.35-1.76)
0.55
Overlapping stents
27/299 (9.0)
15/287 (5.2)
1.73 (0.94-3.18)
0.07
Bifurcation lesion
18/244 (7.4)
14/221 (6.3)
1.17 (0.59-2.29)
0.66
Lesion length > 27 mm
13/160 (8.1)
14/157 (8.9)
0.91 (0.44-1.88)
0.80
In-stent restenosis
2/27 (7.4)
4/28 (14.3)
0.52 (0.10-2.60)
0.67
Left main treated
1/19 (5.3)
1/21 (4.8)
1.11 (0.07-16.47)
1.00
Bypass graft treated
3/24 (12.5)
3/31 (9.7)
1.29 (0.29-5.84)
1.00
Renal insufficiency
6/35 (17.1)
3/28 (10.7)
1.60 (0.44-5.83)
0.47
All
55/905 (6.1)
47/905 (5.2)
1.17 (0.80-1.71)
0.47
0.1
Resolute Integrity
better
RVD=reference vessel diameter.
Subgroup analysis was non-prespecified.
1.0
10
Promus Element
better
Longitudinal Stent Deformation
Stent in mid RCA
Entering with prox. stent
Longitudinal stent
deformation (LSD)
LSD
Stented
segment
C. von Birgelen, Thoraxcentrum Twente, Enschede, Netherlands
Longitudinal Stent Deformation
• Angiograms of all patients were reviewed for stent deformation (LSD).
• LSD was defined as distortion or shortening of an implanted stent in the
longitudinal axis following successful initial deployment.
• LSD was noted on angiograms of 9 patients of the Promus Element group
and none of the Resolute Integrity group (9/905 vs. 0/906; p=0.002).
• In the Promus Element group, LSD was seen in 1/100 patients treated
(1%) and in 0.6/100 Promus Element stents implanted (0.6%).
• LSD often triggered postdilation and implantation of additional stents,
but was not associated with any adverse events.
Case
PDSL
Stent type
Diameter
Vessel
Following attempts to re-cross stent
1
0.94
Pr. Element
3.0 mm
LAD
2
0.83
Pr. Element
2.5 mm
RCA
3
0.74
Pr. Element
3.5 mm
LAD
4
0.79
Pr. Element
2.25 mm
LAD
Following very oversized postdilatation
5
0.94
Pr. Element
2.25 mm
LAD
6
0.87
Pr. Element
3.5 mm
Left main
Following contact with guiding or balloon catheter
7
0.81
Pr. Element
2.5 mm
RCA
8
0.91
Pr. Element
3.0 mm
LAD
9
0.84
Pr. Element
3.0 mm
RCA
Lesion
Characteristics
Postdilation
Additional
prox. stent
Association with
clinical event
C
C
C
C
bifurcation
severe calcification
bifurcation
bifurcation
+
+
+
–
+
+
+
+
none
none
none
none
C
B2
severe calcification
bifurcation
+
+
+
–
none
none
C
C
C
bifurcation
moderate calcification
severe calcification
+
+
+
+
+
–
none
none
none
PDSL means post-deployment stent length ratio, defined as final stent length divided by stent length immediately after
deployment. Cases 2 and 4 are female patients. Lesion types were assigned according to ACC/AHA lesion classification.
LAD=left anterior descending artery. LSD=longitudinal stent deformation. Pr.=Promus. RCA=right coronary artery.
Conclusion
Use of third-generation zotarolimus-eluting Resolute
Integrity stents and everolimus-eluting Promus Element
stents in an “all-comers” population resulted in excellent
clinical outcomes, especially in view of the large number
of patients treated for acute myocardial infarction.
Efficacy and safety of the Resolute Integrity stent were
similar to that of the Promus Element stent.
DUTCH PEERS
(TWENTE II)
Simultaneous publication online in The Lancet
DUTCH PEERS
Trial Organization
Steering Committee
C. von Birgelen, MD PhD (PI)
P. Danse, MD PhD
G.A.J. Jessurun, MD PhD
Study Centers and Local PIs
Thoraxcentrum Twente, Enschede
C. von Birgelen, MD PhD
Scheper Hospital, Emmen
G.A.J. Jessurun, MD PhD
Rijnstate Hospital, Arnhem
P. Danse, MD PhD
Medical Center Alkmaar, Alkmaar
R.W.M. Hautvast, MD PhD
Study Team Thoraxcentrum Twente
H. Sen, MD
M.K. Lam, MD
M.M. Löwik, PhD
M.W.Z. Basalus, MD PhD
K. Tandjung MD
C. von Birgelen, MD PhD
Monitoring
CRO Diagram, Zwolle
R. Dekker, RN
Data Management
CRO CardioResearch Enschede
H.J.P. Verheij, RN
R.E. van der Leest
J. van Es, MD
J.W. Louwerenburg, MD
Angiographic Analysis
Angiographic Core Lab at TC Twente
I. Valkenburg, BSc
J.C. Jonge Poerink, RN
Clinical Event Adjudication
CRO Cardialysis, Rotterdam
P.P. Kint, RN
W. Lindeboom, MSc
Clinical Event Committee:
P. Vranckx, MD PhD (chair)
H.M. Garcia-Garcia, MD PhD
J. Wykrzykowska, MD PhD
Statistical Analysis
K. Tandjung, MD
C.J.M. Doggen, PhD
Investigator-initiated study, equally supported by Boston Scientific and Medtronic
Backup Slides
DUTCH PEERS
(TWENTE II)
 Any patient requiring DES (stable angina, any ACS, including STEMI)
 No limit of number of lesions or vessels treated, lesion length, vessel size, or
lesion type (de novo lesion, restenosis, CTO, graft lesion)
Zotarolimus eluted
within < 180 days
from a 5.6 µm
BioLinx™ polymer
coating on
an Integrity stent
platform with 91µm
CoCr2 struts
 Inclusion criteria: Age ≥ 18 yrs; patient requires PCI with DES implantation and is able
and willing to comply with study procedures and follow-up procedures; signed
informed consent
 Exclusion criteria: Participation in another randomized drug or device trial before
reaching its primary endpoint; life expectancy < 1yr; planned surgery < 6 mo’s of PCI
unless DAPT is maintained; known pregnancy; intolerance to heparine, ASA,
clopidogrel, or DES components
Zotarolimus-eluting
RESOLUTE INTEGRITY
1811 All-comer patients were enrolled in this singleblinded, investigator-initiated, randomized (1:1)
trial in Arnhem, Emmen, Alkmaar & Enschede
(n=906)
Everolimus eluted
within < 120 days
from a 7 µm
fluoropolymer
coating on an
Element stent
platform with 81µm
PtCr2 struts
Everolimus-eluting
PROMUS ELEMENT
(n=905)
30 days
1 year
2 years
Control angiography only if clinically indicated
Primary endpoint
Target vessel failure at one year (composite of cardiac death, target vessel-related MI,
and clinically driven target vessel revascularization; non-inferiority hypothesis)
Secondary endpoints Components of primary endpoint; stent thrombosis; patient oriented composite endpoint
Enrollment: November 25, 2010 to May 24, 2012. Systematic (serial) assessment of cardiac markers and ECG. Monitoring of informed consent and key demographic data in all patients;
monitoring of data on potential clinical events in patients with event triggers; in-depth monitoring of all data in 10% of randomly chosen patients. Monitoring performed by CRO Diagram,
Zwolle, NL. Processing of clinical outcome data and independent external adjudication of clinical events (CEC) by CRO Cardialysis, Rotterdam, NL.
Analyses based on intention-to-treat. 1-Year follow-up available in 99.9% of patients.
von Birgelen et al. Third-generation zotarolimus-eluting and everolimus-eluting
stents in all-comer patients requiring a PCI (DUTCH PEERS). Lancet – in press.
Investigator-initiated study, equally funded by Boston Scientific and Medtronic
Longitudinal Stent Deformation
Longitudinal stent deformation (LSD) after very oversized
postdilation of stents (bench top, unconstrained model)
LSD
C. von Birgelen, Thoraxcentrum Twente, Enschede, Netherlands
Mod. from: C. von Birgelen, presented at EuroPCR 2010 in Paris, France.
Longitudinal Stent Deformation
LSD in distal stent
+ contact between
guiding catheter tip
and proximal stent
LSD
C. von Birgelen, Thoraxcentrum Twente, Enschede, Netherlands
LSD in the distal stent resulted from recrossing the distal stent with a balloon catheter.
Longitudinal Stent Deformation
Stent in mid RCA
Entering with prox. stent
Longitudinal stent
deformation (LSD)
LSD
Stented
segment
C. von Birgelen, Thoraxcentrum Twente, Enschede, Netherlands

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